Bard InLay Ureteral Stent with NiCore GuidewireRecalls & reported problems across all models

We found 7 models of Bard InLay Ureteral Stent with NiCore Guidewire by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Oct 26, 2021 and Jun 26, 2026 — classified as 24 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (19 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Bard InLay Ureteral Stent with NiCore Guidewire problems

Bard InLay Ureteral Stent with NiCore Guidewire models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bard® InLay® Ureteral Stent with NiCore™ Guidewire 776724

  STENT, URETERAL
  16 reports
• Bard® InLay® Ureteral Stent with NiCore™ Guidewire 776626

  STENT, URETERAL
  15 reports
• Bard® InLay® Ureteral Stent with NiCore™ Guidewire 776624

  STENT, URETERAL
  7 reports
• Bard® InLay® Ureteral Stent with NiCore™ Guidewire 776426

  STENT, URETERAL
  6 reports
• Bard® InLay® Ureteral Stent with NiCore™ Guidewire 776424

  STENT, URETERAL
  4 reports
• Bard® InLay® Ureteral Stent with NiCore™ Guidewire 776428

  STENT, URETERAL
  4 reports
• Bard® InLay® Ureteral Stent with NiCore™ Guidewire 776622

  STENT, URETERAL
  4 reports

Recent Bard InLay Ureteral Stent with NiCore Guidewire adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Difficult to Insert; Difficult to Advance

  IT WAS REPORTED THAT THE PHYSICIAN OPENED THE STERILE PACKAGING, REMOVED THE STENT AND GUIDEWIRE, LUBRICATED THEM WITH STERILE WATER, AND ASSEMBLED THE STENT AND GUIDEWIRE IN PREPARATION FOR CATHETERIZATION. DURING THE PROCEDURE, IT WAS DISCOVERED THAT ONCE PART OF THE STENT HAD ENTERED THE PATIENT¿S BODY, IT COULD NO LONGER BE ADVANCED, RESULTING IN A FAILED CATHETERIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25643267 ↗
• MalfunctionApr 9, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED BY CRITICAL CARE NURSES IN AN ONLINE SURVEY, AND THEY STATED THAT IN CHARTS 3 AND 4, IN THE ONLINE SURVEY A DR. IN QUESTION: "DO YOU BELIEVE THE BENEFITS OF USING THE INLAY AND INLAY VERSAFIT URETERAL STENTS OUTWEIGH THE POTENTIAL RISKS (I.E. DO THE PROS OUTWEIGH THE CONS)?" SHE OR HE ANSWERED "NO, THE BENEFITS OF USING THIS PRODUCT DO NOT OUTWEIGH THE POTENTIAL RISKS.¿ BECAUSE "WHILE THE PRODUCT OFFERS SEVERAL BENEFITS, THERE ARE SOME POTENTIAL RISKS THAT REQUIRE CONSIDERATION. THE RISKS INCLUDE DATA PRIVACY CONCERNS, LEARNING CURVE FOR NEW USERS, AND POTENTIAL INTEGRATION CHALLENGES WITH EXISTING SYSTEMS. ADDITIONALLY, THERE MAY BE COST BENEFIT CONSIDERATIONS THAT NEED TO BE WEIGHED MORE CAREFULLY IN CERTAIN USE CASES. ", ALSO, IN CHARTS 3 AND 5 IN THE ONLINE SURVEY IN QUESTION: "WAS THE STENT SUCCESSFUL IN RELIEVING URETERAL OBSTRUCTION TO ALLOW FOR URINE " SHE OR HE ANSWERED "NO¿ BECAUSE "TOO SMALL " IN BOTH CHARTS. IN CHART 5 IN THE ONLINE SURVEY A IN QUESTION: "DID THE GUIDEWIRE SUPPORT STENT PLACEMENT PROCEDURE? SHE OR HE ANSWERED "NO¿ BECAUSE "DOESN'T FIT " THE CODE OF PRODUCT IS CHART 3 777400 AND CHART 5 776428.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832438 ↗
• InjuryApr 4, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY STATED THAT IN CHART 3, IN THE ONLINE SURVEY A DR. IN QUESTION: "PLEASE SPECIFY IF ANY OF THE FOLLOWING ADVERSE EVENTS OCCURRED AS A RESULT OF THE DEVICE (I.E. PLEASE INDICATE IF THE PATIENT EXPERIENCED ANY DEVICE RELATED ADVERSE EVENTS). " SHE/HE ANSWERED THE FOLLOWING AES: CHART 3- URETERAL REFLUX, PAIN/DISCOMFORT, INFECTION, HEMATURIA. ALSO, THE RESPONDENT IN QUESTION "DID THE URETERAL REFLUX, PAIN/DISCOMFORT, INFECTION, HEMATURIA RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION? OF NOTE: ANY ACTION AS A RESULT OF AN ADVERSE EVENT IS CONSIDERED MEDICAL INTERVENTION (E.G. PRESCRIBING ANY MEDICATION AS A RESULT OF AN ADVERSE EVENT, SURGERY AS A RESULT OF AN ADVERSE EVENT, ETC.)" SHE/HE ANSWERED WITH "NO" IN ALL LOOPS. IN ADDITION, IN QUESTION "DID THE PATIENT EXPERIENCE ANY OF THE FOLLOWING COMPLICATIONS PRIOR TO DEVICE PLACEMENT OF INLAY URETERAL STENT WITH NICORE GUIDEWIRE?" SHE/HE ANSWER WITH THE FOLLOWING COMPLICATIONS: URINARY SYMPTOMS, HEMATURIA. THE CODE OF PRODUCT IS CHART 3- 776424.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Pain

  MAUDE report 24785555 ↗
• InjuryJan 22, 2026Calcified

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT URETEROSCOPIC LASER LITHOTRIPSY AND LEFT URETERAL STENT PLACEMENT. THE PROCEDURE WAS SMOOTH, AND THE INTERNAL STENT DRAINED WELL. ONE MONTH LATER, THE PATIENT RETURNED AS INSTRUCTED FOR PLANNED STENT REMOVAL. INTRAOPERATIVELY, A LARGE AMOUNT OF STONE ADHERED TO THE ENTIRE SURFACE OF THE RENAL PELVIC END OF THE URETERAL STENT, PREVENTING ITS REMOVAL. HOLMIUM LASER LITHOTRIPSY WAS PERFORMED TO REMOVE MOST OF THE STONES ON THE URETERAL STENT, AND THE STENT WAS COMPLETELY REMOVED FROM THE URETER USING FOREIGN BODY FORCEPS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24157803 ↗
• InjuryDec 4, 2025Calcified; Calcified

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT LASER LITHOTRIPSY AND LEFT URETERAL STENT PLACEMENT. THE PROCEDURE WAS SUCCESSFUL, AND THE STENT DRAINAGE WAS UNOBSTRUCTED. ONE MONTH LATER, THE PATIENT RETURNED TO THE HOSPITAL AS INSTRUCTED FOR STENT REMOVAL. DURING THE PROCEDURE, NUMEROUS STONES WERE FOUND ADHERING TO THE ENTIRE SURFACE OF THE STENT, MAKING REMOVAL DIFFICULT. HOLMIUM LASER LITHOTRIPSY SURGERY WAS PERFORMED TO REMOVE MOST OF THE STONES FROM THE URETERAL STENT, AND THE STENT WAS COMPLETELY REMOVED FROM THE URETER USING FOREIGN BODY FORCEPS. PATIENT BEEN EXPOSED TO HAZARDOUS SUBSTANCES, BLOOD, OR BODILY FLUIDS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Exposure to Body Fluids

  MAUDE report 23717297 ↗
• InjuryDec 4, 2025Calcified; Calcified

  IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT NEPHROLITHOTRIPSY WITH HOLMIUM LASER LITHOTRIPSY VIA URETEROSCOPE AND RIGHT URETERAL STENT PLACEMENT. A URETERAL STENT WAS PLACED INTRAOPERATIVELY. THE PROCEDURE PROCEEDED SMOOTHLY WITH UNOBSTRUCTED DRAINAGE. ONE MONTH LATER, THE PATIENT RETURNED AS INSTRUCTED FOR URETERAL STENT REMOVAL. INTRAOPERATIVELY, EXTENSIVE CALCULUS ADHESION WAS OBSERVED ON THE STENT SURFACE. HOLMIUM LASER LITHOTRIPSY WAS PERFORMED TO REMOVE THE URETERAL STONES AND EXTRACT THE STENT, RESULTING IN BLEEDING. SOLUTION: HOLMIUM LASER LITHOTRIPSY WAS PERFORMED TO REMOVE MOST OF THE STONES ADHERING TO THE URETERAL STENT. THE INTACT STENT WAS THEN EXTRACTED USING FOREIGN BODY FORCEPS. SURGICAL INTERVENTION WAS PERFORMED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23717293 ↗
• MalfunctionJun 17, 2024Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT THE URETERAL STENT WAS READY FOR IMPLANTATION. THE USER PULLED THE WIRE TOO HARD, CAUSING THE STENT RING TO BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19546975 ↗
• MalfunctionApr 15, 2024Calcified; Calcified

  CRITICAL CARE NURSES REPORTED IN A PMCF A PHYSICIAN STATED THAT THEIR PATIENT EXPERIENCED STENT ENCRUSTATION AFTER PLACEMENT OF THE DEVICE. THE RESPONDENT INDICATED THEY BELIEVED THE COMPLICATION TO BE A PROCEDURE RELATED COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106197 ↗
• MalfunctionMar 29, 2024Complete Blockage; Complete Blockage

  CRITICAL CARE PHYSICIAN REPORTED IN A PMCF THAT STENT WAS NOT SUCCESSFUL IN RELIEVING URETERAL OBSTRUCTION TO ALLOW FOR URINE DRAINAGE BECAUSE "THE SPLINT OCCLUDED DURING THE PERIOPERATIVE PERIOD" IN RELATION TO "776428 - INLAYTM URETERAL STENT WITH NICORE NITINOL/NITINOL GUIDEWIRE,4.7 FR.,28CM".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19007106 ↗
• InjuryMar 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT CRITICAL CARE NURSES REPORTED IN AN PMCF THAT THE PATIENT ADMITTED FOR STENT REMOVAL EXPERIENCED AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO THE DEVICE 776626 - INLAYTM URETERAL STENT WITH NICORE NITINOL/NITINOL GUIDEWIRE,6 FR.,26CM AND THE PATIENT EXPERIENCED URINARY SYMPTOMS. THIS DID RESULTED IN THE PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 18977980 ↗
• MalfunctionApr 13, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHEN DELIVERING THE URETERAL STENT DURING OPERATION, THE STENT COULD NOT BE ENTERED. ANOTHER KIT WAS UNPACKED SUBSEQUENTLY AND THE OPERATION WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732518 ↗
• MalfunctionMar 20, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT WAS RUPTURED UPON UNPACKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16578727 ↗
• MalfunctionNov 7, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE URETERAL STENT COULD NOT BE PUSHED INTO THE PELVIS DURING OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15744690 ↗
• MalfunctionNov 7, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT WAS RUPTURED UPON OPENING OF THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743461 ↗
• MalfunctionOct 10, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT WAS BROKEN IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15572816 ↗

Other C. R. Bard, Inc. products

• Bardex I.C. Foley Catheter26 models · 3,607 reports
• Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
• Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
• Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
• Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
• Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
• PureWick Female External Catheter5 models · 1,184 reports
• Bardex All-Silicone Foley Catheter12 models · 1,170 reports